Policy and Communications Bulletin

POLICY AND COMMUNICATIONS BULLETIN

THE CLINICAL CENTER

Medical Administrative Series

MXX-X

MANUAL TRANSMITTAL SHEET

SUBJECT: Reimbursement of Travel and Subsistence Expenses

for NIH Clinical Research Protocol Participants

1. Explanation of Material Transmitted: This issuance transmits the policy and procedures of the Clinical Center on reimbursement of travel and subsistence expenses for participants in NIH Intramural Clinical Research Protocols. Specifically, it establishes the requirement for each protocol to establish a protocol-specific reimbursement rate for travel (i.e., local and long-distance transportation) and subsistence (i.e., meals and lodging) and the requirement for clinical research protocol participants to be reimbursed in accordance with these established protocol-specific reimbursement rates. This policy was approved by the Medical Executive Committee on XXXXXXX.

2. Material Superseded: None

3. Filing Instructions: [insert name of filing section here]

Insert: No. MXX-X, dated XX

4. Distribution: NIH Institutes and Centers (IC), IC Clinical Directors, Principal Investigators, IC research coordinators, Institute Review Boards, Clinical Center (CC) Office of Protocol Services, CC Social Work Department, CC Voucher Office, NIH Cashier’s Office, CC Patient Travel Coordinator.

5. Additional Information:

Additional information is available online at http://intranet.cc.nih.gov/patienttravel

Links to relevant documents (where available) can be found in Section I: References.

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POLICY AND COMMUNICATIONS BULLETIN

THE CLINICAL CENTER

Medical Administrative Series

MXX-X Draft 3/12/2008

SUBJECT: Reimbursement of Travel and Subsistence Expenses

for NIH Clinical Research Protocol Participants

A. PURPOSE:

This chapter establishes a policy for reimbursement of travel and subsistence expenses for participants in clinical research protocols at all NIH intramural clinical research sites.

B. GUIDING PRINCIPLES:

NIH will make every effort to assure fairness in reimbursing clinical research protocol participants for travel and subsistence by taking into account the scientific needs of the studies and the financial and/or medical needs of individual participants.

No U.S. citizen or permanent U.S. resident residing in the U.S. who otherwise meets eligibility requirements will be denied enrollment in clinical research protocols because of their inability to pay the costs of travel and subsistence.

C. POLICY:

This policy establishes the requirement for each protocol to establish a protocol-specific reimbursement rate for travel (i.e., local and long-distance transportation) and subsistence (i.e., meals and lodging) ranging from zero up to the government rate. Participants will be made aware of the protocol-specific reimbursement rate as part of the enrollment process. Each participant will be provided reimbursement at the specified rate upon request.

Participants needing additional financial assistance will be able to receive supplemental reimbursement based upon need. Requests for supplemental reimbursement will be evaluated on a case-by-case basis for valid financial and/or medical need through a standardized process.

In establishing the travel and subsistence reimbursement rates for a protocol, Principal Investigators (PIs) must consider a set of objective factors, including reimbursement practices of similar protocols at the NIH, the rarity of the disease being studied, the benefit/burden being placed on the subject and family, and special needs of the participants. These factors will be used by Institutional Review Boards (IRBs) in approving the reimbursement rates to assure that proposed reimbursement practices are equitable.

In setting reimbursement levels for lodging, protocols must specify whether they will authorize use of The Children's Inn and The Edmond J. Safra Family Lodge. If use of these lodging facilities is authorized, full reimbursement at the current nightly rates will be required.

D. SCOPE:

This policy applies to U.S. citizens or permanent U.S. residents residing in the U.S. (and parent/guardian for pediatric protocol participants or authorized attendant for adults) enrolling in research protocols that take place at NIH intramural clinical research sites, including protocols located on the NIH campus in Bethesda, Maryland, and at all other NIH intramural locations.

For participants whose home of record is outside the U.S., travel expenses from a U.S. port of entry may be covered.

The specific procedures for implementation will vary by site; however, all applicable travel guidelines outlined in the procedures section of this policy must be followed.

This policy does not address the issue of compensation that may be offered under a protocol other than reimbursement for travel and subsistence for participants.

E. DEFINITIONS:

Protocol-Specific Reimbursement Rate: Amount of financial coverage provided to clinical research protocol participants (and parent/guardian for pediatric protocol participants or authorized attendant for adults) for travel and subsistence by the sponsoring Institute or Center (IC). This rate can range from zero up to the government rate. The parameters of coverage are detailed in Section F of this policy.

Supplemental Reimbursement: Additional financial assistance, above the protocol-specific reimbursement rate, made available to clinical research protocol participants with valid financial and/or medical need. Generally, supplemental reimbursement extends coverage up to the full government rate; however, ICs may authorize supplemental reimbursement above the full government rate on an as-needed basis (e.g., a participant may require two airline seats for medical necessity).

Travel: Transportation of a person by car, bus, train or plane; refers to both local and long-distance. The parameters of coverage are detailed in Section F of this policy.

Subsistence: Refers to meals and lodging. The parameters of coverage are detailed in Section F of this policy.

F. PARAMETERS OF COVERAGE:

The mode of travel approved will be the least expensive unless otherwise authorized.

NIH will pay for expenses that involve travel from the home of record to the NIH site. Unless medically indicated, NIH will not pay for expenses that involve alternate routes. Unnecessary stops or delays along the way for sight seeing, visits, vacations, or to increase frequent flyer miles will not be authorized, even if it makes the travel less expensive.

NIH will not pay for expenses that are incurred beyond the approved time period of the visit.

Local Travel: Protocol participants who live within 50 miles of the NIH clinical research site are eligible for reimbursement of local travel at the protocol-specific reimbursement rate. The approved modes of local travel are as follows:

· Car: The government will reimburse participants for car mileage. Reimbursement for rental cars will not be allowed beyond the car mileage reimbursement rate.

· Taxi/Train/Bus: Participants traveling by taxi, train, or bus will be reimbursed if authorized.

Long-Distance Travel: Protocol participants who live more than 50 miles of the NIH clinical research site are eligible for reimbursement for long-distance travel at the protocol-specific reimbursement rate. The approved modes of long-distance travel are as follows:

· Air: The government will pay for air transportation from the airport nearest to the home of record to the least expensive airport near the NIH clinical research site.

· Train: The government will pay for train tickets.

· Car: The government will pay for car mileage provided the cost of the round trip does not exceed a round trip government-rate airline ticket. Reimbursement for rental cars will not be allowed beyond the car mileage reimbursement rate.

· Bus: The government will pay for bus tickets provided the cost of the round trip does not exceed a round trip government-rate airline ticket.

Lodging: Participants will be provided reimbursement for lodging expenses in accordance with the protocol-specific reimbursement rate for participants living greater than 50 miles from the NIH clinical research site. If the hotel cost is less than the protocol-specific reimbursement rate, NIH will only reimburse for the actual cost of the lodging.

Meals: The NIH will provide reimbursement in accordance with the protocol-specific reimbursement rate for meals at a daily rate.

G. PROCEDURES:

1. establishing the protocol-specific reimbursement rate

During the development of a new protocol or at the time of renewal for existing protocols, the PI will complete the “Designation of Reimbursement of Travel and Subsistence (DRTS) Expenses for NIH Intramural Clinical Research Protocols” (Form NIH 2868). In completing the DRTS form, the PI will consider the disease characteristics, benefit/burden to participants, scientific need and the reimbursement practices of similar protocols and will determine a protocol-specific reimbursement rate for travel and subsistence expenses. The protocol reimbursement rate can range from zero up to the government rate.

The DRTS form (Appendix A) can be accessed from the CC Office of Protocol Services (301-496-0744) at http://intranet.cc.nih.gov/ops/ and at http://intranet.cc.nih.gov/patienttravel. Investigators can query protocols to identify protocols with similar disease characteristics identified on the DRTS Form, as well as by reimbursement, protocol number, or PI at http://pqs.cc.nih.gov/protocol_query/pi_institute_search.

The PI or designee and the CC Office of Protocol Services will ensure that each protocol consent document (upon establishment or at the time of annual review if the protocol is still actively accruing participants) includes the following statement:

“Reimbursement of travel and subsistence will be offered consistent with NIH guidelines.”

The PI will sign the completed DRTS form and submit it, along with the consent document, to the Institutional Review Board (IRB) as a part of the protocol review package.

2. approving the protocol-specific reimbursement rate

The IRB will ensure that the protocol review package includes a completed DRTS form and a new consent document as referenced in Section G.1.

The IRB will review the DRTS form as part of the protocol review package to ensure that the PI has considered the relevant factors in establishing the protocol-specific reimbursement rate.

The protocol-specific reimbursement rates will be considered effective as of the date of the final IRB approval.

3. informing participant of the policy, protocol-specific reimbursement rate and reimbursement options

The PI or designee will inform prospective and current protocol participants of the policy on Reimbursement of Travel and Subsistence Expenses for NIH Clinical Research Protocol Participants and the protocol-specific reimbursement rate (for air/rail travel, car mileage, meals and lodging). The PI or designee may opt to send written documentation to prospective and current protocol participants describing this policy and the protocol-specific reimbursement rate. A sample generic notification memorandum is available at http://intranet.cc.nih.gov/patienttravel.

The PI or designated IC research coordinator will explain the three reimbursement options to the participant and will ask the participant to select one:

Accept protocol-specific reimbursement
Decline reimbursement
Request supplemental reimbursement for financial or medical need

4. entering the reimbursement option selected by participant

Once a reimbursement option is selected by a protocol participant, the PI or designated IC research coordinator will document the participant’s selection in the Admissions/Travel/Voucher (ATV) system. If applicable, the PI or designated IC research coordinator will initiate a request for a financial or medical needs assessment in the ATV system which generates a service request to the CC Patient Travel Coordinator.

5. explaining travel planning steps to participant

The PI or designee will explain the travel planning steps that correspond with the selected reimbursement option:

a. Participant ACCEPTS protocol-specific reimbursement

if the protocol-specific reimbursement rate is set at (or above) the government rate

for air/rail travel:

The PI or designee will direct the participant to contact the Patient Travel Office to have air or rail travel arranged and paid by the government. The PI or designee will instruct the participant to arrange and pay for his/her own lodging. The PI or designee will inform the participant to keep receipts for reimbursement of lodging and other travel expenses.

if the protocol-specific reimbursement rate is set below the government rate for

air/rail travel:

The PI or designee will instruct the participant to arrange his/her own air or rail travel and lodging at his/her own expense. The PI or designee will inform the participant to keep receipts for reimbursement of these and other travel expenses. The participant may contact the Patient Travel Office for assistance with air/rail travel planning.

b. Participant DECLINES reimbursement

The PI or designee will inform the participant to arrange ALL travel and lodging at his/her own expense. The participant may contact the Patient Travel Office for assistance with air/rail travel planning.

c. Participant REQUESTS supplemental reimbursement

if the request is for financial need:

The PI or designee will inform the participant that he/she will be contacted by the CC Patient Travel Coordinator who will conduct an in-person or phone interview to evaluate financial need using a standardized assessment tool that was developed by the Social Work Department. Within three days of the interview, the CC Patient Travel Coordinator will evaluate the participant’s responses and record the results of financial assessment in the ATV system. The PI or designee will check the results of the financial assessment in the ATV system and inform the participant of the decision.

If the participant is approved for supplemental reimbursement, the PI or designee will then instruct the participant to follow the appropriate travel planning steps from Section 5A. If participant is denied supplemental reimbursement but accepts instead the protocol-specific reimbursement rate, the PI or designee will then instruct the participant to follow the appropriate travel planning steps from Section 5A.

Requests for evaluation of financial need for supplemental reimbursement received after business hours will be handled by the Social Worker on call. The Social Work Department will be consulted in the review of supplemental reimbursement requests as needed.

if the request is for medical need:

The PI or designee will determine if supplemental reimbursement for medical need should be provided to the participant. This determination is based on individual participant need and the scientific/recruitment needs of the protocol. As a management control, the CC Patient Travel Coordinator will review supplemental reimbursements for medical necessity to ensure that patient travel funds are the appropriate funding mechanism to cover the request. If patient travel funds are not the correct funding source, the CC Patient Travel Coordinator will contact the PI or designee to determine alternative resources. The PI or designee will specify the supplemental reimbursement amount in the ATV system and inform the participant of the decision.